Effect of an Interactive Computer Program to Prevent Alcohol Misuse. A Multicentre Randomized Controlled Trial. The BREVALCO Study.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 601
- 试验地点
- 2
- 主要终点
- The mean number of alcohol drinks by day in the previous week, at 12months.
研究概览
简要总结
The purpose of this study is to evaluate the effect of a brief computer program to prevent alcohol misuse for patients consulting in an emergency department and screened for alcohol misuse.
详细描述
Purpose: to evaluate the effect of a brief computer program to prevent alcohol misuse for patients consulting in an emergency department and screened for alcohol misuse.
Design: A randomized controlled trial with patients blinded of study hypotheses. Randomization will be stratified on centers and the sex
Interventions:
Patients randomized in the experimental group will participate in an interactive computer program with video, questionnaires and information related to alcohol misuse. They will also be contacted by phone at 1 month and 3 months to reinforce the effect of the intervention.
Patients randomized in the control group will participate in an interactive computer program with questionnaires and information related to healthy diet. They will also be contacted by phone at 1 month and 3 months to reinforce the effect of the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age >=18
- •patients consulting in an emergency department
- •screened for alcohol misuse or dependence (i.e. for women: AUDIT score>5 or consumption of more than 14 alcohol drinks per week For men: AUDIT score>8 or consumption of more than 7 alcohol drinks per week)
- •informed and signed consent form
- •clinical exam performed
- •having social protection
排除标准
- •vital risk
- •patients having mental disorder,
- •patient unable to answer the questions and to participate in the computer program because of their clinical condition
- •patients no understanding French languages
- •patient already being treated for alcohol disorder
- •patients asking for a specific treatment for their alcohol disorder
- •patients unable to answer to the follow-up visits
结局指标
主要结局
The mean number of alcohol drinks by day in the previous week, at 12months.
时间窗: 12 months
次要结局
- the percentage of consultations at an ED at 12 months,(12 months)
- the rate of acceptance of a long-term follow-up(12 months)
- the DSM-IV-TR criteria of alcohol abuse or dependence at 12 months(12 months)
- the percentage of consultations at hospital at 12 months,(12 months)
- the AUDIT score (0-40) at 12 months,(12 months)
- the mean number of drunkenness or alcohol intoxications with behaviour problems per day in the previous week at 12 months,(12 months)
- Three numerical scales of social satisfaction (0 to 10) based on health, family life or relationship, occupation or daily activity at 12 months,(12 months)
- the rate of suicide attempts.(12 months)